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FDA 510(k)

TAMPON, UNTREATED

K-Number: K912941 · 1992-03-06

ApplicantHygieia Healthcare , Ltd.
Decision Date1992-03-06
Product CodeHEB
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

TAMPON, UNTREATED is the device name listed in this FDA 510(k) record. The listed applicant is Hygieia Healthcare , Ltd.. It received FDA 510(k) clearance on 1992-03-06 under 510(k) number K912941. The device is classified under product code HEB. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TAMPON, UNTREATED?

TAMPON, UNTREATED is a medical device that received FDA 510(k) clearance on 1992-03-06. The listed applicant is Hygieia Healthcare , Ltd.. The 510(k) number is K912941.

When did TAMPON, UNTREATED receive FDA 510(k) clearance?

TAMPON, UNTREATED received FDA 510(k) clearance on 1992-03-06, under 510(k) number K912941.

Who is the listed applicant for TAMPON, UNTREATED?

The FDA 510(k) record lists Hygieia Healthcare , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TAMPON, UNTREATED?

The FDA product code for TAMPON, UNTREATED is HEB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Hygieia Healthcare , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K954445NON APPLICATOR TAMPON, UNTREATEDK950194TAMPON, UNTREATED

Related Devices (Code: HEB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252005Livi DeviceLiviwell, Inc.K253719Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital TamponsUnibeauty (Hubei) Technology Co., Ltd.K252939COHITECH ORGANIC COTTON COMPACT APPLICATOR TAMPONSCotton High Tech S.L.K252613Unscented menstrual three-piece applicator tamponUnibeauty (Hubei) Technology Co., Ltd.K251033Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator Tampon; Unscented menstrual Cardboard Applicator Tampon; Unscented menstrual Digital TamponsUnibeauty (Hubei) Technology Co., Ltd.K242105SABA TamponsEssity Higiene Y Salud Mexico. S.A. DE C.V.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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